Trials / Completed
CompletedNCT05414981
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
A Randomized, Blinded, Placebo-Controlled, Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Assembly Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABI-H3733 | 25 mg or 100 mg tablets for oral administration |
| DRUG | Placebo | 25 mg or 100 mg tablets for oral administration |
Timeline
- Start date
- 2022-08-07
- Primary completion
- 2023-04-24
- Completion
- 2023-04-24
- First posted
- 2022-06-10
- Last updated
- 2023-06-29
Locations
9 sites across 6 countries: Bulgaria, Hong Kong, Moldova, New Zealand, Romania, Singapore
Source: ClinicalTrials.gov record NCT05414981. Inclusion in this directory is not an endorsement.